Status:
COMPLETED
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GL...
Detailed Description
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR (Study Drug). IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into the brain around the c...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years old.
- Patients must have clinical and/or radiographic evidence of FIRST recurrence or progression of supratentorial GBM afer a previous resection or biopsy and external beam radiation therapy.
- Patients must have histopathologic documentation of GBM at initial diagnosis.
- Patients must have had previous cytoreductive surgery or biopsy for GBM.
- Patients must have received external beam radiotherapy with ≥ 45 Gy tumor dose, completed ≥ 4 weeks prior to study entry.
- Gross total resection (i.e., ≥ 95% resection of the solid, contrast-enhancing tumor component) must be planned.
- Tumor must have a solid contrast-enhancing component ≥ 1.0 cm in diameter. Baseline measurements must be obtained ≤ 2 weeks prior to study entry.
- Patients must be in adequate condition, as indicated by:
- Karnofsky Performance Score ≥ 70,
- Adequate hematologic status: i. Absolute neutrophil count (ANC) ≥ 1,500/mm3; ii. Hemoglobin ≥ 10 gm/dL; iii. Platelets ≥ 100,000/mm3; iv. PT and aPTT ≤ 1.5 x institutional upper limit
- Patients must not be receiving concurrent anti-tumor therapy and must have recovered from toxicity of prior therapy. Minimum intervals required:
- ≥ 6 weeks after receiving nitrosourea cytotoxic drug
- ≥ 4 weeks after receiving any non-nitrosourea cytotoxic drug or any systemic investigational agent
- ≥ 2 weeks after receiving any non-cytotoxic anti-tumor drug (including celecoxib or other drugs, if they are being used as anti-tumor therapies)
- Patients must be willing to practice an effective method of birth control during the study. Female patients must not be pregnant or breast-feeding.
- Patients or legal representative must understand the investigational nature of this study and sign a written informed consent form, approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC), prior to performance of any study-specific procedure
Exclusion
- Patients with contrast-enhancing tumor component crossing the midline, multi-focal tumor not amenable to gross total resection, or tumor dissemination (subependymal or leptomeningeal).
- Expected communication between ventricle and resection cavity that cannot be repaired in order to safely use GLIADEL® Wafer.
- Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment.
- Patients who have received any type of stereotactic radiosurgery or brachytherapy, with the exception of the stereotactic radiosurgery boost part of the initial fractionated external beam radiation therapy.
- Patients who have received:
- 1\) prior treatment with IL13-PE38QQR, or, 2) GLIADEL® Wafer, or, 3) any intracerebral investigational agent
- Patients who have demonstrated a previous hypersensitivity to BCNU or any other component of the GLIADEL® Wafer.
- Patients unwilling or unable to follow protocol requirements.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00076986
Start Date
February 1 2004
End Date
March 1 2007
Last Update
June 6 2011
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham - Division of Neurosurgery
Birmingham, Alabama, United States, 35294-3410
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
3
Los Angeles County/USC
Los Angeles, California, United States, 90033
4
Cedars-Sinai Medical Center - Neurological Institute
Los Angeles, California, United States, 90048